BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESTIGE CERVICAL DISC SYSTEM

    MDR report key: 2516586 · Received April 4, 2012

    Report

    Report Number
    1030489-2012-00406
    Event Type
    Injury
    Date Received
    April 4, 2012
    Report Date
    March 7, 2012
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    MJO
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED DURING THE (B)(4) STUDY PRIOR TO DEVICE APPROVAL. THE APPROVED DEVICE PRODUCT CODE IS MJO AND THE PMA NUMBER IS P060018. (B)(4). THE DEVICE OR APPLICABLE IMAGING STUDIES HAVE NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO DETERMINE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    APPROXIMATELY 42 MONTHS POSTOPERATIVELY, STUDY X-RAYS DEMONSTRATED SOME SETTLING OF THE DISC SPACE WITH SOME SMALL AMOUNT OF LUCENCY JUST ABOVE THE DISC SPACE ADJACENT TO THE IMPLANT. NO TREATMENT WAS REQUIRED. APPROXIMATELY 58 MONTHS POSTOPERATIVELY, THE PATIENT HAD NO SYMPTOMS, NORMAL RANGE OF MOTION, AND THE IMPLANT WAS IN GOOD POSITION. APPROXIMATELY 83 MONTHS POSTOPERATIVELY, DURING A FOLLOW-UP APPOINTMENT, IT WAS NOTED THAT THE SCREWS INFERIOR TO THE ARTIFICIAL DISC WERE BROKEN IN THE C6 VERTEBRAL BODY. NO TREATMENT WAS GIVEN. THE STUDY SITE NOTED THAT THE LUCENCY ABOVE THE DISC SPACE ADJACENT TO THE IMPLANT REMAINED UNCHANGED. NO TREATMENT WAS GIVEN. APPROXIMATELY 84 MONTHS POSTOPERATIVELY, A MYELOGRAM SHOWED FRACTURED C6 FIXATION SCREWS AND OSSIFICATION PRESENT AT THE POSTERIOR MARGIN OF THE C5-C6 INTERSPACE. THE PATIENT UNDERWENT REVISION SURGERY WHICH INCLUDED EXPLANT OF THE ARTIFICIAL DISC, ANTERIOR DISCECTOMY AND FUSION AT C5-C6 WITH ALLOGRAFT AND TITANIUM ANTERIOR PLATE, POSTERIOR LATERAL MASS SCREW INSTRUMENTATION, AND C5-C6 POSTEROLATERAL ARTHRODESIS WITH DBM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESTIGE CERVICAL DISC SYSTEM MJO WARSAW ORTHOPEDICS NA 080200

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention